CLINICAL
NEWS JACC in a FLASH
Featured topics in the current and recent
issues of the JACC family of journals
already had new cerebral emboli visible on MRI and suggest that larger
trials are needed to explore this issue.
They also suggest that further, larger
studies are needed to explore optimal
antiplatelet therapy, with special attention to the early period after TAVR.
“While dual antiplatelet therapy after
TAVR is recommended, the duration
varies, and the dosage and timing of
a loading dose of clopidogrel remain
unspecified,” they write.
Van Belle E, Hengstenberg C, Lefevre T, et
al. J Am Coll Cardiol. 2016;doi:10.1016/j.
jacc.2016.05.006
All-women
Registry Provides
Findings on TAVR
Cerebral Embolization Common in Outcomes
TAVR Patients
Nearly two-thirds of patients who
undergo transcatheter aortic valve
replacement (TAVR) experience
cerebral embolization, according to
results from the BRAVO-3 MRI study
presented at the EuroPCR 2016 meeting in Paris and published in JACC.
The overarching BRAVO-3 study
was a randomized trial comparing bivalirudin with unfractionated heparin
in patients undergoing tansfemoral
TAVR. In this substudy, 60 patients
were imaged with brain MRI after
TAVR. The primary endpoint was
the proportion of patients with new
cerebral emboli on MRI.
The proportion of patients with
at least one new post-procedural cerebral emboli on MRI was 61.7% and
did not differ between patients who
were treated with bivalirudin and
those who were treated with heparin. The proportion of patients with
a large embolus volume did also not
differ between groups. All patients
who presented clinically with stroke
18
CardioSource WorldNews: Interventions
showed evidence of new emboli on
MRI. The total volume of emboli, the
volume of single embolus per patient,
and the volume of the largest embolus
per patient were higher in patients
presenting with stroke compared t o
those without stroke at 30 days. The
median number of lesions was 1 (0 to
3) in bivalirudin group and 1 (0 to 1)
in the heparin group.
The results from the BRAVO-3
MRI study, coupled with the findings
from recent MRI studies, highlight
the need for additional dedicated
MRI studies with high rates (> 80%)
of post-procedural MRI, according
to the study authors. They note that
“although stroke rates after TAVR are
low, the high incidence of neurembolic events remains to be addressed,
as the occurrence of ‘silent’ embolic
lesions can lead to acceleration of
cognitive decline.” Calling the silent
embolic lesions the “hidden iceberg
of clinical stroke,” they point out that
all six patients with a clinical stroke
Data from the first all-women
transcatheter aortic valve replacement (TAVR) registry, presented at
EuroPCR 2016 and published in
JACC: Cardiovascular Interventions,
offers a look at which factors, such as
prior pregnancy, may lead to better
outcomes for women.
The study, led by Alaide Chieffo,
MD, looked at 1,019 women enrolled
in 20 European and North American
centers between Jan. 2013 and Dec.
2015 and participating in the Women
in Transcatheter Aortic Valve Implantation (WIN-TAVI), a multinational,
prospective, observational registry of
women undergoing TAVR for aortic
stenosis.
The mean patient age was 82.5
± 6.3 years, mean EuroSCORE I was
17.8 ± 11.7%, and mean Society of
Thoracic Surgeons (STS) score was
8.3 ± 7.4%. TAVR was performed
via transfemoral access in 90.6%;
new-generation devices were used in
42.1%. The primary endpoint was the
Valve Academic Research Consortium
(VARC)-2 early safety endpoint at 30
days—composite of all-cause mortality, all stroke, major vascular complication, life-threatening bleeding, stage
2 or 3 acute kidney injury (AKI),
coronary artery obstruction requiring
interventions or repeat procedure for
valve-related dysfunction.
Women in this study were found
to be at an intermediate to high risk
compared to women in prior TAVR
studies. The 30-day VARC-2 composite
endpoint occurred in 14.0%, with 3.4%
all-cause mortality, 1.3% stroke, 7.7%
major vascular complications, and
4.4% VARC life-threatening bleeding.
Independent predictors of the primary
endpoint were age (odds ratio [OR],
1.04; 95% confidence interval [CI],
1.00–1.08), prior stroke (OR, 2.02;
95% CI, 1.07–3.80), ejection fraction
< 30% (OR, 2.62; 95% CI, 1.07–6.40),
device 4 generation (OR, 0.59; 95%
CI, 0.38–0.91), and history of pregnancy (adjusted OR, 0.57; 95% CI,
0.37–0.85).
According to Chieffo and colleagues, their findings demonstrate
that the independent predictors of
the 30-day VARC-2 composite safety
endpoint are increasing age, history
of prior stroke, left ventricular ejection fraction < 30% and TAVR device
generation. Additionally, a remote
history of pregnancy was found to be
associated with a lower rate of this
endpoint. Patients without a history
of pregnancy were more likely to be
smokers, with significant left main
artery disease or severely calcified
aortic valves. They were also more
often considered frail. Past pregnancy
was not observed to influence 30-day
mortality, vascular or bleeding endpoints but impacted the incidence of
30-day composite death or stroke.
Moving forward, the study authors
recommend a randomized assessment
of TAVR versus surgical aortic vascular repair (SAVR) in intermediate-risk
women with severe AS to determine
optimal treatment strategies for this
population.
Chieffo A, Petronio AS, Mehilli J, et al. JACC
Cardiovasc Interv. 2016;doi:10.1016/j.
jcin.2016.05.015
July/August 2016